C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 5F; CHRONIC CATHETERS
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Model Number 0720515 |
Device Problem
Difficult to Flush (1251)
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Patient Problems
Fever (1858); Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2026).
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Event Description
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It was reported that four days post catheter placement procedure, the catheter allegedly had a difficulty in flushing.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: b5, d4 (expiry date: 05/2026).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Event Description
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It was reported that four days post catheter placement procedure, the catheter allegedly had a difficulty in flushing.It was further reported that the patient allegedly experienced neutropenic fever and sepsis which was treated in hospital upon removing the port.The procedure was completed using another device.The current status of the patient was unknown.
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